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Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Maryland
New York State Office of Mental Health (OMH)
Maryland Department of Health and Mental Hygiene
Information provided by (Responsible Party):
Lisa Dixon, Research Foundation for Mental Hygiene
ClinicalTrials.gov Identifier:
NCT01216891
First received: October 4, 2010
Last updated: June 26, 2013
Last verified: April 2013

October 4, 2010
June 26, 2013
October 2010
June 2013   (final data collection date for primary outcome measure)
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This measures occupational functioning, social functioning and symptom severity.
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
  • The Mental Illness Research Education and Clinical Center Global Assessment of Functioning (MIRECC GAF) [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01216891 on ClinicalTrials.gov Archive Site
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • Calgary Depression Scale [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • Calgary Depression Scale [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • Calgary Depression Scale [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 15 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 21 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • The Clinical Global Impression (CGI) - Severity scale [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
    This assesses the level of severity of illness.
  • Calgary Depression Scale [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 15 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 21 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Calgary Depression Scale [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
    This assesses depression in people with schizophrenia.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 15 ] [ Designated as safety issue: No ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 21 ] [ Designated as safety issue: No ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
    This assesses suicide risk, including the content and intensity of suicidal thoughts and behaviors.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 3 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 9 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 15 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 18 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 21 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
    This measures the presence and severity of symptoms of schizophrenia.
Not Provided
Not Provided
 
Multi-disciplinary Treatment for Patients Experiencing First Episode of Psychosis
Recovery After an Initial Schizophrenia Episode (RAISE): The RAISE Connection Program

This study will assess the effectiveness of an experimental treatment intervention for adolescents and adults who have experienced their first episode of psychosis during the past two years.

This study is part of the National Institute of Mental Health's Recovery After an Initial Schizophrenia Episode (RAISE) Project. The RAISE Project seeks to fundamentally change the trajectory and prognosis of schizophrenia through coordinated and aggressive treatment in the earliest stages of illness. This study, the RAISE Connection Program, is one of the two independent research studies that NIMH has funded to conduct the NIMH RAISE Project. The Connection Program is being supported in whole or in part with Federal funds from the American Recovery and Reinvestment Act of 2009 and the NIMH, National Institutes of Health, Department of Health and Human Services. The Connection Program aims to to assess the effectiveness of a Team-based intervention for individuals with a first psychotic episode, observing outcomes over time for our study participants. When tracking outcomes, the Connection Program will make comparisons with what is known about the natural history of untreated first episode of psychosis as well as usual care outcomes from other experimental studies.

This study is for people who have experienced symptoms such as hallucinations, unusual thoughts or beliefs, or disorganized thinking for the first time during the past two years. Without treatment, many people have a difficult time with these symptoms, which can be very upsetting and also make it hard to socialize, study, or work.

People have different wishes and needs, and it is not clear what combination of treatments and services is best for any one person. There are many possible treatments and services, such as medications, talk therapy, case management, and school and job counseling. This study will adapt and evaluate the impact of a comprehensive and integrated treatment intervention for first episode psychosis to be delivered in real-world practice settings to promote symptomatic recovery, minimize disability, and maximize social, academic, and vocational functioning.

Participation in this study will last up to 2 years. At the baseline visit, participants will be enrolled to receive the experimental intervention. During the study period, participants will take part in research interviews every three to six months for a total of 6 interviews. Each of these research interviews will take 1.5 to 3 hours to complete. Assessments of participants' health condition, overall function and illness severity, employment status, academic performance, and social functioning will be conducted during these research interviews. In addition to assessing functioning and illness severity, this study will also address substance abuse and utilization of healthcare services. Participants will also be measured for their height, weight and waist circumference.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Schizoaffective Disorder
  • Schizophreniform Disorder
  • Delusional Disorder
  • Psychosis
Behavioral: Multi-element, team-oriented treatment
Participants will receive treatment and services based on their needs coordinated by a small team that is led by a clinical coordinator. Services that are available to the participants include social skills training, medication treatment to address symptoms, education and employment advising, and substance use treatment.
Experimental: Team-based treatment
Intervention: Behavioral: Multi-element, team-oriented treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
65
December 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age range: 15-35 years old (16-35 years old in New York)
  • Diagnosis of schizophrenia, schizoaffective and schizophreniform disorder, delusional disorder, or psychosis not otherwise specified (NOS)
  • Duration of psychotic symptoms > 1 week and < 2 years
  • Ability to provide informed consent
  • Ability to speak and understand English
  • Anticipated availability to participate in the intervention for at least 1 year

Exclusion Criteria:

  • Medical conditions which impair function independent of psychosis
  • Other diagnoses associated with psychosis:
  • Substance-induced psychotic disorder
  • Psychotic affective disorder (major depressive or manic episode with psychotic features)
  • Psychotic disorder due to a general medication condition
  • Mental retardation
Both
15 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01216891
RAISE Connection, HHSN271200900020C
Yes
Lisa Dixon, Research Foundation for Mental Hygiene
Research Foundation for Mental Hygiene, Inc.
  • National Institute of Mental Health (NIMH)
  • University of Maryland
  • New York State Office of Mental Health (OMH)
  • Maryland Department of Health and Mental Hygiene
Principal Investigator: Lisa Dixon, MD Columbia University
Principal Investigator: Melanie Bennett, PhD University of Maryland
Research Foundation for Mental Hygiene, Inc.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP